# FDA recall Z-1499-2020

> **Philips North  America, LLC** · Class II · device recall initiated 2020-02-26.

## Product

HeartStart MRx Monitor/Defibrillators with model numbers M3535A  M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5,   M3536M6, M3536M7, M3536M8, and M3536M9.

## Reason for recall

Philips has received a number of reports of HeartStart MRx Monitor/Defibrillators that have suffered internal damage and were not able to deliver therapy after having been dropped or subjected to a severe mechanical shock, even though the device did not have visible external damage or the Ready for Use ( RFU ) indicator on the unit did not immediately indicate a problem.  One of these reports involved a death of a patient who could not be resuscitated.

## Distribution

US Nationwide domestic distribution. Worldwide foreign distribution.

## Key facts

- **Recall number:** Z-1499-2020
- **Recalling firm:** Philips North  America, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-26
- **Report date:** 2020-03-25
- **Termination date:** 2022-12-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1499-2020

## Citation

> AI Analytics. FDA recall Z-1499-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1499-2020. Source: US FDA. Licensed CC0.

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